FDA approves Omontys for kidney disease-related anemia

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for anemia in patients with chronic kidney disease.

The FDA announced the approval of Affymax’s Omontys (peginesatide), a drug belonging to the class known as erythropoiesis-stimulating agents, designed to aid the formation of red blood cells.

"Omontys represents the first new FDA-approved and marketed ESA for this condition since 2001," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "This new drug offers patients and healthcare providers the convenience of receiving ESA therapy just once per month instead of more frequent injections."

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Techs are front-line warriors to boost drug safety

If you’re a pharmacy technician in any practice setting, you’re at the front lines of an escalating battle to prevent medication errors and save lives. Spurred by growing alarm over the human and financial toll of adverse drug events, a web of powerful health agencies, professional pharmacy organizations and patient-safety advocates are waging a campaign to reduce medication errors by boosting safeguards in the pharmacy and educating patients. But the success of that effort hinges in large part on how pharmacy technicians perform their duties at the nexus of care between patient and pharmacist.

“Reducing medication errors … has become a significant priority, especially over the last few years,” noted Megan Sheahan, director of professional affairs for the Pharmacy Technician Certification Board. “But there are still a lot of things that need to happen within every pharmacy to reduce errors.”

One priority, Sheahan said, is improving communication among techs and pharmacists. “Technicians need to have increased dialogue with the pharmacist throughout all the checking processes and every other part of the medication fill process they’re involved in,” she asserted. “And technicians need to be empowered to initiate that dialogue.”

Mike Johnston, chairman and CEO of the National Pharmacy Technician Association, also stressed the need for a team approach to eliminating medication misadventures. “Pharmacy technicians are going to be essential in addressing medication errors,” he said. “The role of the technician is completely embedded in the process of preventing medication errors and misadventures.”

The reason is simple, Johnston told Collaborative Care: “For a majority of patients, their first interaction with the pharmacy is going to be with the technician. If the tech is able to review what the script was at time of drop-off and have a verbal communication with the patient there, if there are any discrepancies, it triggers action.”

In addition, NPTA’s CEO said, “the tech is going to be the individual entering the prescription order into the computer system in most cases. And in most cases, the technician is the last individual to communicate with the patient when they pick up the prescription, review the medication and go over the patient’s and the doctor’s name. So you’ve got three critical points there in the life cycle of a potential medication misadventure, where a pharmacy technician can take a very proactive role in prevention.”

A team approach
Pharmacists, for their part, are fully supportive of pharmacy techs as allies in the campaign to prevent errors and improve safety. “Pharmacy technicians are valuable employees when it comes to safe and accurate dispensing,” agreed Lisa Schwartz, PharmD, who directs management affairs for the National Community Pharmacists Association. “Technicians are capable of detecting medication errors at the point of data entry, during prescription preparation and when patients pick up their order. Pharmacists can leverage technicians to prevent confirmation bias and gather information from patients to prevent errors.”

For instance, Schwartz noted, “is the Casodex prescription written for J. Doe for Jane or her husband, John?” In addition, she told Collaborative Care, “pharmacists rely on technicians to detect unusual dose or direction changes and as the technician gains experience, possibly unusual drug selection.”

For that reason, Schwartz said, “in addition to a basic screening of incoming prescriptions, technicians must pay great attention to detail and accurately transcribe information on a prescription to the label for dispensing; accurately select and count or measure the medication; and ensure that the verified prescriptions get to the right patient. And depending on pharmacy workflow, the pharmacist or technician may be responsible for assembling the will-call bag.”

The nation’s oldest national pharmacist organization, the American Pharmacists Association, also is enlisting pharmacy technicians in the campaign to improve drug safety. Among the group’s recommendations are advances in “accredited education and training programs that develop qualified pharmacy technicians who will support pharmacists in ensuring patient safety and enhancing patient care,” according to APhA spokeswoman Michelle Fritts.

Citing an analysis of medication errors made by pharmacy techs from [the United States Pharmacopeial Convention] and the Institute for Safe Medication Practices, the APhA noted that while many of those errors were intercepted prior to reaching patients, 12% of those that weren’t caught led to a near-death experience or death. The answer, according to the pharmacist group: increased training and a “uniform set of standards” for techs.

The APhA developed a set of recommendations for error-prevention techniques within the pharmacy, many of which involve the typical duties of pharmacy technicians. Among them: working on one patient’s script at a time and keeping each in a separate bin; returning stock bottles to shelves immediately after use to avoid overcrowding the work counter; turning a used drug stock bottle upside-down to avoid mix-ups; double-checking bar codes against the national drug code number; and having two different staff members check the prescription.

That last point can be critical. “Up to 90% of errors will be caught when another set of eyes is looking at the prescription and doing a double check,” observed Allen Vaida, EVP of the Institute for Safe Medication Practices. “The technicians present that extra set of eyes.”

The PTCB, for its part, is working to enhance the tech’s role in drug safety. For instance, Sheahan said, “we want techs to learn how to report medication errors” through the National Medication Errors Reporting Program, a Web-based reporting system offered through ISMP that tracks and compiles data on drug dispensing errors, adverse drug reactions and other threats to medication safety. “Pharmacy technicians can play an integral role in that program,” she noted.

PTCB will soon launch a new toolbox for technicians on its website that includes links to ISMP and other resources, Sheahan said. “These resources are out there and available to technicians, but we wanted to find a way to simplify it and put it all in one place.”

The speed versus accuracy debate
One trend pharmacy advocates see as extremely counterproductive to the drive for improved dispensing accuracy is the effort by some retail pharmacies to speed up the dispensing process as a customer convenience. Promises to fill customers’ prescriptions within 15 minutes, for instance, run counter to the drug safety effort, they asserted.

The two goals, Vaida said, are contradictory. “But that’s often the consumer’s perception: ‘How fast can I get in and get out?’ And if the pharmacy is now promoting that message, it just adds to the problem,” he noted. NPTA’s Johnston agreed, and said the competition over who can get a script out the fastest is putting pharmacists and technicians under “tremendous pressure.”

“Something’s got to give,” he warned. “As a profession and an industry, we’re doing the population a great disservice to promote speed over accuracy. The purpose of pharmacy is not to get the med out as quickly as possible; it’s to provide accurate and effective pharmaceutical care. And part of that is going to require patient education … to dispel those myths on what the public perceives as the goal of the pharmacy team. If the public really understood that, I think we could lessen the burden and expectations of a fast-food mentality.”

“Patients are willing to sit for hours to go to a physician they can trust. I don’t think it’s inappropriate for there to be the same expectation of an adequate waiting time to go to a pharmacy they can trust,”
Johnston added.

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Medication mix-ups: A deadly toll

It’s common knowledge that pharmaceuticals have provided humankind with almost miraculous benefits over the past century in their ability to prevent, cure or reduce the impact of disease and to prolong life. But serious errors in the way medicines are dispensed by pharmacies and self-administered by patients are taking a big and growing toll on patients’ well-being.

Adverse drug events related to dispensing errors, unforeseen drug interactions, dosing errors and other problems are killing thousands of Americans each year and costing the U.S. health system and economy tens of billions of dollars in additional acute care costs and lost productivity. One estimate from the Institute of Medicine of the National Academies said medication errors injure at least 1.5 million people a year and account for at least $3.5 billion in additional hospital costs alone each year for Medicare.

Concern over this patient safety reached a crescendo in late 1999 with the publication of “To Err Is Human,” a report from the IOM that attributed as many as 98,000 preventable deaths to medical errors each year. Those findings spurred new legislation and regulations, including passage in 2005 of the Patient Safety and Quality Improvement Act. The law directed the Department of Health and Human Services to establish “a framework by which hospitals, doctors and other healthcare providers may voluntarily report information to Patient Safety Organizations, on a privileged and confidential basis, for the aggregation and analysis of patient safety events,” according to the Government Accountability Office.

Compounding the problem, said Michael Cohen, president of the Institute for Safe Medication Practices, is the fact that “we are treating more patients and they are sicker to start with, so they don’t tolerate some of the errors that [occur].” In addition, he said, “many of the drugs we use today and the way we use them makes it more likely that harm will occur when errors happen.”

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